Biothera Pharmaceuticals, Inc. is a privately held biotechnology company with class-leading expertise in the development of novel biologics that robustly activate the innate immune system to drive an anti-cancer T cell response. Biothera is committed to developing Imprime PGG in combination with immune checkpoint inhibitors (CPIs) in multiple Phase 2 cancer indications.
Imprime PGG is a novel dectin receptor agonist that reverses tumor-mediated immunosuppression and promotes antigen presentation, eliciting the activation and subsequent infiltration of tumor-specific, killer T cells into tumor tissues. Imprime PGG is the only systemically administered innate immune activator. Other innate immune activators, including TLR, cGAS- STING, RIG-I and NOD-like agonists, are being developed clinically in combination with checkpoint inhibitors but are typically restricted to direct intra-tumoral injection to avoid systemic toxicity. Imprime PGG has been safely administered by intravenous infusion to nearly 600 human subjects.
Our clinical development strategy is to establish clinical and mechanistic proof of concept for Imprime PGG in combination with CPIs in multiple cancer indications. Our initial focus is on tumor types and patient populations wherein single agent CPI therapy has provided limited benefit. These tumor types include metastatic triple negative breast cancer, CPI-failed advanced melanoma, colorectal cancer and non-small cell lung cancer. Phase 2 clinical studies are underway and research collaborations have been established with Merck and Genentech. To enhance the likelihood of clinical and regulatory success for Imprime PGG, our clinical studies are interlaced with a robust translational research program designed to demonstrate that Imprime PGG appropriately activates an anti-cancer immune response systemically and within the tumor itself.
Imprime PGG’s therapeutic mechanism of action is immune cell-specific, rather than cancer cell-specific. Accordingly, Imprime PGG may be useful in activating and sustaining anti-cancer immunity in multiple cancer types with PD-1 and PD-L checkpoint inhibitors, as well as inhibitors of alternate immune checkpoints, such as anti-TIM, LAG, VISTA and CD47. In addition, the rich clinical history and mechanistic understanding of Imprime PGG suggest broader clinical development opportunities in combination with tumor-targeting antibodies (e.g. rituximab), anti-angiogenics (e.g. bevacizumab) and other anti-cancer immune therapies (CD40 agonists, tumor vaccines).